Cordis Announces Positive Results from Two Major Studies Demonstrating Durable Efficacy of SELUTION SLR™ Drug-Eluting Balloon in Complex Peripheral Artery Disease Patients

• SELUTION SLR™ Drug-Eluting Balloon (DEB) achieves amongst the highest reported patency for any drug-eluting or drug-coated technology at 3 years in the SELUTION SFA Japan Trial, with 81.5% primary patency.
• SELUTION SLR™ DEB demonstrates real-world effectiveness and consistency across complex and varied patient populations. The SUCCESS Study 12-month primary endpoint showed: Freedom from CD-TLR – overall population of 91.1%, claudicants 91.3%, and CLTI 90.3%.

MIAMI LAKES, Fla., April 24, 2025 /PRNewswire/ -- Cordis, a global leader in interventional cardiovascular and endovascular technologies, announced new data from two major peripheral studies evaluating the SELUTION SLR™ Drug-Eluting Balloon (DEB). The SUCCESS PTA Study 12-month results were presented on April 23 at the Charing Cross Symposium in London. The SELUTION SFA Japan Trial 3-year results followed on April 25 at the Japan Endovascular Treatment Conference in Osaka. The studies confirm the sustained efficacy and safety of SELUTION SLR™ DEB in treating complex peripheral artery disease (PAD) across diverse, real-world patient populations, favorably matching best-in-class benchmarks from paclitaxel-eluting technologies.

3-Year Results – SELUTION SFA Japan Trial: First Sirolimus DEB with Proven Long-Term Outcomes

The SELUTION SFA Japan trial, a prospective, single-arm trial conducted at 13 sites across Japan, evaluated the performance of SELUTION SLR™ DEB in 134 complex patients. At 3 years, SELUTION SLR™ DEB demonstrated primary patency of 81.5% and freedom from Clinically Driven Target Lesion Revascularization (CD-TLR) of 93.8%. These results demonstrate that SELUTION SLR™ DEB is the only drug-eluting technology with core-lab adjudicated 3-year patency over 80%.

"SELUTION SLR™ DEB represents the next evolution in Leave-Nothing-Behind treatment strategies. These 3-year outcomes demonstrate unprecedented durability in complex patients with primary patency greater than 80%. In contrast, paclitaxel drug-coated balloon studies have shown significant loss of patency in the same time period," said Dr. Iida, MD, of the Cardiovascular Division at Osaka Police Hospital, Japan and Study Principal Investigator.

12-Month Outcomes – The SUCCESS PTA Study: Real-World Results in a PAD Population

The SUCCESS PTA Study is a prospective, observational global registry evaluating SELUTION SLR™ DEB in 723 patients across 27 sites in Europe, Asia, and South America. The study population reflects real-world practice, with 74.2% of patients presenting with claudication and 25.8% with chronic limb-threatening ischemia (CLTI). The primary endpoint—freedom from CD-TLR at 12 months—was consistently high: 91.1% in the overall population, 91.3% in claudicants, and 90.3% in CLTI patients. Clinical improvements were seen across the patient cohorts with 88.1% of patients improving by at least one Rutherford category.

"Leveraging SELUTION SLR™ DEB with its unique sirolimus MicroReservoir technology delivers unequivocal clinical benefits in complex patient cohorts," said Dr. Michael Lichtenberg, Chief of Interventional Angiology at Klinikum Hochsauerland, Germany, CMO and Director of Vascular Center Clinic, Germany, and Study Principal Investigator. "These real-world results demonstrate consistent safety and effectiveness in both claudicant and CLTI patients." 

Drug Elution, Done Better – Sustained Sirolimus Release Improves Outcomes

"At Cordis, our focus is always on advancing therapies that offer meaningful, lasting impact for patients—and these results do exactly that," said Dr. George Adams, Chief Medical Officer at Cordis. "The SELUTION SLR™ studies showcase drug elution, done better – sustained sirolimus delivery results in unmatched and durable efficacy, uncompromised safety and consistent robust real-world data across diverse PAD populations. This is the kind of innovation that truly elevates patient care."

About Cordis
Cordis is a global leader in the development and manufacturing of interventional cardiovascular and endovascular technologies. For over 60 years, we have been committed to improving patient lives through innovation, enhanced clinical outcomes, education, and service. Our mission is to be the heart of innovation to transform cardiovascular care.

For more information about Cordis, please visit Cordis.com and follow Cordis on LinkedIn.

Media Contact:
Kelly May
Director of Corporate Communications
kelly.may@cordis.com

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SOURCE Cordis